Issue 159

Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.

 E&O Fridays.

Here’s what’s going on in FDA-regulated and pharma-focused digital health:

• First off, a detour into the big news this week… Amazon’s multi-billion dollar acquisition of One Medical is a tectonic shift for health tech, if not health care in the US (let’s wait and see on the latter). While there are endless takes and Twitter threads to pore through, spare a thought for Amazon’s on-site and near-site primary care clinic partner Crossover Health. As E&O detailed in The Crossover Health Report back in April 2021, Crossover appeared to be banking on an acquisition by Amazon after the tech giant became its largest customer by revenue. Amazon bought One Medical instead. So, now what?
• Back to FDA-regulated digital health: The agency granted Aussie-listed connected inhaler company Adherium a new 510(k), which I believe marks the 12th version of the company’s Haillie sensor with market authorization in the States. While the company has yet to announce the clearance and the agency hasn’t posted a summary document yet, this is likely a connected inhaler device that Adherium built for GSK. The date of submission lines up with an FDA submission announcement Adherium made back in March: “Adherium’s latest Hailie sensor, designed for use with the GlaxoSmithKline (GSK) Ellipta dry powder inhaler (DPI), is the second in Adherium’s series of new sensors, following AstraZeneca’s Symbicort pMDI inhaler, specifically designed to capture physiological parameters such as respiratory flow rate in litres per minute. This additional information and reporting adherence provides a new, never before available window into inhaler usage and technique giving patients immediate feedback and promoting greater engagement with the Hailie phone app. Recording inhaler adherence and physiological parameters also empowers the patient-physician relationship with remote, automated and objective data to guide patient care and support patient management.”
• Germany added a new prescription digital therapeutic to its national formulary. This is the 35th DiGa to be listed on the platform, but two have been removed so far leaving 33 DiGas currently available to prescribers. The new DiGa is the fifth one from GAIA. The provisionally listed prescription digital therapeutic, named optimune, uses cognitive behavioral therapy (CBT) to treat stress in patients with breast cancer who have completed their initial treatment. It runs €952 for a 90-day course of treatment and that makes it the most expensive DiGa in the formulary. At about €744, GAIA’s multiple sclerosis DiGA elevida was the most expensive on the platform prior to optimune’s addition. Here’s a link to optimune’s clinical trial results in PubMed.
• So, you’re telling me there is a chance? The House version of the Access to Prescription Digital Therapeutics Act of 2022 bill, which would create a new Medicare benefit category for prescription digital therapeutics, added five new co-sponsors since I last checked in mid-June. The House version of the bill now has 10 co-sponsors, while the Senate bill has yet to add any new supporters since its introduction in March. The five new representatives who support the bill: Rep. Angie Craig (D-MN), Rep. Brian Fitzpatrick (R-PA), Rep. Tom Cole (R-OK), Rep. Yvette Clarke (D-NY), and Rep. Paul Tonko (D-NY).
• One more thing… North Carolina’s state budget proposal includes $1.85 million for a pilot to try out FDA-authorized prescription digital therapeutics for opioid use disorder. It’s a fair assumption that this is yet another Pear Therapeutics pilot: “Budgets opioid settlement funds for a pilot program to explore the effectiveness of prescription digital therapeutics authorized by the federal Food and Drug Administration for the treatment of opioid use disorder. Funding is provided by the Opioid Abatement Fund.”

Did a friend forward this to you? You, too, can win friends and influence people via newsletter forwards by clicking right here. Become the newsletter-forwarder we both know you were meant to be. Act fast! This offer won’t last forever (I am not immortal).

Overview of Biogen’s 11 digital health programs

During its recent investor quarterly update call, Biogen shared an overview of its pipeline of digital health programs, which span Multiple Sclerosis, Alzheimer’s and other dementia, neuromuscular disorders, and more. (Likely no breaking news below, but it’s a helpful overview of digital health at Biogen, so read on if you’re in need of a refresher…)

Of the 11 programs that Biogen has publicly disclosed, the company categorizes only one of them as a digital therapeutic, MR-004, the Multiple Sclerosis-focused prescription digital therapeutic that it is co-developing with MedRhythms.

Biogen lists out four “value creation objectives” for its digital health programs:

• “Potentially improve efficiency of clinical development
• Evidence and companion technologies that may enhance risk/benefit profile of Biogen therapies
• Aim to expand market opportunities (screening, diagnosis, adherence, compliance)
• Potential adjacent source of revenue (prescription digital therapeutics, software as a service – imaging, digital biomarkers etc.)”

Here’s a quick run-through of the 11 digital health projects that Biogen has underway right now:

Biogen’s Multiple Sclerosis-related digital health programs

MR-004 — DTx — Development — MS Patients walking & independence — “Biogen entered into a license agreement with MedRhythms to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis. The investigational prescription digital therapeutic uses a combination of sensors, software, and music based on Rhythmic Auditory Stimulation (RAS).”

Cleo/Aby — Digital Companion — In-Market — Patient Pathway Improvement — “Cleo (Aby in North America) is a digital care companion app to help people live with Multiple Sclerosis. It provides information, tips, symptoms tracking, reminders, tailored programs for self-care such as nutrition, mindfulness, and a nurse chat.”

MS PATHS — Research Network — In-Market — Digital Biomarkers/Personalized Medicine — “Uses advanced technologies to generate & collect standardized patient data during routine office visits potentially resulting in a large, high definition and diverse real-world MS cohort.”

CogEval — Cognitive Assessment — In-Market — Digital Biomarkers/Personalized Medicine — “CogEval is an iPad-based assessment designed to evaluate cognitive function in-clinic for patients with multiple sclerosis.”

MS Performance Test — Digital Biomarkers — In-Market — Digital Biomarkers/Personalized Medicine — “In-clinic assessment tool that aims to objectively quantify the major motor, visual, and cognitive systems, as well as quality of life and disease history for patients with MS. HCPs can access patient results at the point of care.”

Biogen’s Alzheimer’s and dementia-related digital health programs

AI^2 ARIA Identification — Imaging AI — Development — Personalized Medicine — “AI-squared may be integrated in radiologist workflow/PACS and aims to provide validated, automated MRI assessment report of quantification, severity status and location of ARIA-H and ARIA-E events.”

Intuition — Digital Biomarkers — Development — Digital Biomarkers — “Virtual, observational study leveraging the Apple Watch, iPhone, and CANTAB battery to potentially discover digital biomarkers for MCI screening and potentially track cognitive changes in adults.”

Biogen’s neuromuscular-related digital health programs

Physio.me — Digital Companion — Development — Patient Pathway Improvement/Personalized Medicine — “Digital physiotherapy companion that offers to perform at-home, tailored, secure exercise so NMD patients can potentially achieve their goals, measure progress and share progress with their care team.”

Capsule — VR solution — Development — Patient Pathway Improvement — “Evidence-based medical device that combines immersion through virtual reality technology and medical hypnosis to potentially alleviate anxiety related to intrathecal injection procedures.”

Biogen’s other digital health programs (touch on most disease areas)

Konectom (Multiple Sclerosis, neuromuscular disorders, Parkinson’s) — Digital Biomarkers — Validation — Digital Biomarkers/Personalized Medicine — “Smartphone-based digital measurement platform that aims to assess key neurological functions such as cognition, fine and gross motor control, walk, quality of life and mobility in clinical studies, in-clinic or remotely.”

Neurodiem — Digital Portal — In-Market — Patient Pathway Improvement — “Independent information & education portal for HCPs specialized in the care of patients with neurological diseases. Allows HCPs to access scientifically-validated, independent content to help them remain at the forefront of their practice and deliver the best care to their patients.”

AMA to consider new billing codes for remote therapeutic heart monitoring, text-based telemedicine, VR motor-cognitive training and more

The American Medical Association’s CPT Editorial Panel has revealed the billing code applicants for its September meeting. This is, in effect, a sneak peek at what specific digital health services have a chance at seeing reimbursement in the near future.

Below is a list of the new digital health-related (potential) billing codes up for debate at the meeting…

These first two codes are the only ones related to the suite of Remote Therapeutic Monitoring Services codes that E&O has tracked since their inception. RTM currently includes MSK, respiratory, and CBT. The cardiovascular code application above aims to expand them into heart health monitoring services as well, which is curious given that Remote Physiological Monitoring likely already covers a broad swath of cardiovascular monitoring. So, I’m curious to learn more about the nuances behind that request.

The other code applicant wants to establish a way to bill for RTM and RPM when the provider monitors the patient for less than 16 days. Sixteen days of device readings during a 30-day period is the current minimum required by some of these codes.

• Cardiovascular Remote Therapeutic Monitoring Services — Establish code 9X043 to report monitoring of the cardiovascular system
• RPM-RTM less than 16 days — Establish code 9X055 to report monitoring less than 16 days; revise code 99454 to report 16 days or more; revise the Remote Physiologic Monitoring guidelines; establish codes 9X056, 9X057, 9X058 to report monitoring less than 16 days; revise codes 98976, 98977, 989X6 (2023 code set); and revise Remote Therapeutic Monitoring Services guidelines

Here are a handful of relatively straightforward code submissions:

• Remote Uroflowmetry Testing — Establish codes 9X040, 9X041 to report remote multi-day comprehensive uroflowmetry
• Virtual Reality (VR) Facilitated MotorCognitive Training — Establish code X092T to report semi-immersive VR motor-cognitive training
• Full Body Markerless Motion Analysis with AI Processing — Establish code 9X039 to report full body computer-based markerless 3D kinematic and kinetic motion capture with assistive AI processing; and delete code 0693T
• AI-Assisted Oncologic Treatment — Establish code X093T to report augmentative intelligence identification of personalized oncologic treatment

This Category III code application does not specifically mention “remote” monitoring, but it’s hard to imagine this billing code working any other way, right?

• Cat III – Psychedelic Drug Monitoring Services — Establish codes X088T, X089T, X090T, X091T for reporting psychedelic drug monitoring services; and create a new subheading “Continuous Therapeutic Monitoring, Assessment and Intervention for Psychedelic Medication” with guidelines

Finally, this isn’t a request for a new code but rather a modifier to make it clear via the billing record when a telemedicine session was via text message instead of video call or audio call.

• Telemedicine Modifier: Establish a modifier to identify when a text message is the form of communication during virtual check-in visits

Clinical trial updates from Limbix, Click Therapeutics, Aifred Health, Ksana, and WayBetter

This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.

Limbix sets up new SparkRx study to determine feasibility of its digital therapeutic for depression with teens seeking care for heart and GI conditions

Here’s the brief summary of the 40-person study:

And here’s the description of the intervention:

Small change: Click and Boehringer Ingelheim’s prescription digital therapeutic for schizophrenia tweaked secondary outcomes measure

Click Therapeutics and BI’s exploratory study of CT-155, a prescription digital therapeutic candidate for treating schizophrenia made a very small tweak to its secondary outcomes measure. Instead of a three-item scale (worst, better, best) it moved to a seven-item scale:

Now recruiting: Ksana’s Vira digital mental health intervention app comparative study

Northwestern University’s study on Ksana’s digital mental health app Vira is now recruiting by invitation. The researchers are aiming for 130 participants. More:

Now recruiting: Study on Aifred Health’s AI-based clinical decision support tool for depression 

Aifred Health is hoping to recruit 550 participants for its study. There’s not much detail given about the study in the posting, but the official title of the study gives more hints as to the study’s structure, intervention, and purpose:

And here’s the brief description:

Now recruiting: WayBetter’s QuitBet social gaming app for smoking cessation Phase II study WayBetter hopes to recruit 550 participants for its Phase II study:

Links to E&O’s reports, databases, newsletters

The Exits & Outcomes site is designed to make it easy to find long-form research reports, databases, and past newsletter editions. Click below for dedicated pages for each of those categories:

• Read through the long-form E&O research reports here.
• Search and sort the E&O databases here.
• Skim more than 200 past issues of E&O newsletters here.